NCT05397834
Unknown
Phase 1
A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers
Respirent Pharmaceuticals Co Ltd.1 site in 1 country36 target enrollmentStarted: May 11, 2022Last updated:
Overview
- Phase
- Phase 1
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Cmax
Overview
Brief Summary
Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder
Detailed Description
A bioequivalence study of a single dose of Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory blinded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
laboratory-blinded study
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy volunteers of both genders, aged ≥18 and ≤60 years.
- •Subjects with Body Mass Index (ΒΜΙ) ≥18.5 and \<30.0 kg/m
- •Healthy volunteers are declared healthy based on medical history, physical examination, ECG, pulmonary function test (a forced expiratory volume in 1 second (FEV1) \>=80% of the predicted normal value), and clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator.
- •Females who participate in the study are either unable to gestate \[i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration\] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control within 14 days prior to drug administration and throughout the study.
- •Reliable contraception methods are considered the following:
- •combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal progestogen-only hormonal contraception associated with inhibition of ovulation oral, implanable or injectable intrauterine device (IUD) intrauterine hormone-releasing system (IUS) bilateral tubal occlusion vasectomised partner sexual abstinence
- •Subjects that are non-smokers.
- •Subjects that, in the opinion of the principal investigator/medical officer, are able to communicate and comply with the study procedures and protocol restrictions as evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the subject prior to study initiation.
- •Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse.
Exclusion Criteria
- •Hypersensitivity to the active substance(s) or to the excipient (lactose which contains small amounts of milk protein may cause allergic reactions) or related class (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid therapy) of the medicinal product
- •Clinically significant illness or surgery within four weeks prior to dosing.
- •Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure \<90 or \>140 mmHg, seated diastolic blood pressure \<50 or \>90 mmHg or heart rate less than 50 or over 100 bpm) at screening.
- •Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease.
- •History or presence of pulmonary tuberculosis.
- •Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit.
- •History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease.
- •History of significant alcohol or drug abuse within one year prior to the screening visit.
- •Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) \[1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol\].
- •Inability to abstain from alcohol for the duration of study period.
Arms & Interventions
Test
Experimental
Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals
Intervention: Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals (Drug)
Reference
Active Comparator
FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK
Intervention: FLOVENT DISKUS (Drug)
Outcomes
Primary Outcomes
Cmax
Time Frame: 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration]
Maximum plasma concentration, it is read directly from the raw data
AUC(0-t)
Time Frame: 3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
Area under the plasma concentration curve from time 0 to the last measured
Secondary Outcomes
- AUC0-∞(3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration)
- Tmax(3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration)
- t1/2(3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration)
- λz(3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration)
- Residual Area(3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration)
Investigators
Study Sites (1)
Loading locations...
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